Drug product
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.
D-0434-2026
Product summary
- Event
- Event 98581
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0434-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch# 24EU10010, Exp Date: 05/31/2027.
Distribution pattern: US Nationwide , Alaska, and Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility